FDA Device Registration & Listing · SCHIPOL RIJK Noord-Holland, NL · Registration 3003365815
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2005-08-29 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2008-08-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2012-06-13 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2012-06-13 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2006-05-12 |
| OJK | Eye Tray | Ophthalmic | Class 2 | 886.4790 | 2011-07-27 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2008-10-21 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2016-08-26 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2016-08-26 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2008-01-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2008-01-08 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2010-07-23 |
| LWL | Fluid, Intraocular | Ophthalmic | Class 3 | 886.4275 | 2008-01-18 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2005-08-29 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2004-08-10 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1993-01-01 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2012-12-13 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2020-08-06 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1119279 | Bausch & Lomb Incorporated | CLEARWATER, FL, US |
| 1920664 | Bausch & Lomb Incorporated | Saint Louis, MO, US |
| 1032500 | Bausch & Lomb Incorporated | GREENVILLE, SC, US |
| 3007583964 | TOTAL TITANIUM, INC. | Red Bud, IL, US |
| 1281950 | Bausch & Lomb Incorporated | WILMINGTON, MA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K091915 | Lenstec, Inc. | FLUID ISOLATION DEVICE | 2009-10-27 |
| K830812 | Alphamedix, Inc. | ALPHAMEDIX I/A HAND-PIECE, 500-001 | 1983-06-08 |
| K133115 | Abbott Medical Optics, Inc. | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | 2014-02-27 |
| K121721 | Abbott Medical Optics, Inc. | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | 2012-10-15 |
| K111697 | Abbott Medical Optics, Inc. | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | 2011-09-27 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-1670-2013 | Abbott Medical Optics, Inc. | 2 | Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. |
| Z-0099-2024 | Alcon Research, LLC | 2 | Constellation Vision System, REF: 8065751150 |
| Z-0305-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PAK,I/A LINE,NGVS
8065750957 ASSY,SHIP,CONSTELLATION VFC
8065750972 ENDOILLUMATOR,RFID,23G
8065751014 CONST AUTO GAS FILL PAK
8065751014 CONST AUTO GAS FILL PAK
8065751441 ENDOILLUMINATOR,RFID,25G
8065751577 CHANDELIER,25GA,W/RFID
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-1794-2020 | Alcon Research LLC | 2 | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. |
| Z-2109-2025 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Combined Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console.
Component: N/A |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8040278 | Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, PK |
| 9616972 | TITAN SURGICAL | KAZAN Tatarstan, RU |
| 3006677911 | Crestpoint Management Ltd. | Crestwood, MO, US |
| 3006541044 | Asuzna | Sialkot Punjab, PK |
| 3007648354 | FETZER MEDICAL GMBH & CO.KG | Tuttlingen Baden-Wurttemberg, DE |
3003365815 when referencing this establishment in official correspondence.